[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5657 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5657

   To amend the Federal Food, Drug, and Cosmetic Act to ensure that 
 eligible product developers have competitive access to approved drugs 
  and licensed biological products, so as to enable eligible product 
  developers to develop and test new products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 18, 2014

Mr. Stivers (for himself and Mr. Welch) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to ensure that 
 eligible product developers have competitive access to approved drugs 
  and licensed biological products, so as to enable eligible product 
  developers to develop and test new products, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fair Access for Safe and Timely 
Generics Act of 2014'' or the ``FAST Generics Act of 2014''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Reference product license or approval holders are 
        restricting competitive access to reference products by 
        sponsors seeking to develop drugs, generic drugs, and 
        biosimilars under section 505(b) or 505(j) of the Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(b)(2) and 355(j)) and under 
        section 351 of the Public Health Service Act (42 U.S.C. 262). 
        These restrictions are deterring and delaying development of 
        generic drugs and biosimilars by extending lawful patent-based 
        monopolies beyond their lawful patent life.
            (2) The enforcement provisions set forth in section 505-
        1(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355-1(f)(8)) have not been sufficient to prevent anti-
        competitive practices that interfere with access to reference 
        products which is necessary for the timely development of 
        affordable generic drugs and biosimilars.
            (3) The opinion in Verizon Communications Inc. v. Law 
        Offices of Curtis V. Trinko, LLP, 540 U.S. 398 (2004) should 
        not be construed to impair or bar the application of the 
        antitrust laws consistent with the provisions of this Act.
            (4) There is not a regulatory structure in place that is 
        sufficient to deter or remedy the anti-competitive harm that 
        results when access to reference brand products is restricted 
        to sponsors developing drugs, generic drugs, and biosimilars in 
        accordance with section 505(b) or 505(j) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355(b)(2) and 355(j)), and 
        section 351 of the Public Health Service Act (42 U.S.C. 262), 
        respectively.
            (5) Requiring license holders to comply with requirements 
        for competitive access to their products, and subjecting 
        license holders to antitrust liability for failing to do so, 
        will not impose obligations on the courts that they cannot 
        adequately and reasonably adjudicate.

SEC. 3. COMPETITIVE ACCESS TO COVERED PRODUCTS FOR DEVELOPMENT 
              PURPOSES.

    (a) In General.--Chapter V of the Food Drug and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended by inserting after section 505-1 of such 
Act (21 U.S.C. 355-1) the following new section:

``SEC. 505-2. COMPETITIVE ACCESS TO COVERED PRODUCTS FOR DEVELOPMENT 
              PURPOSES.

    ``(a) Definitions.--In this section:
            ``(1) Covered product.--The term `covered product' means 
        any drug approved under section 505 or any biological product 
        that is licensed under section 351 of the Public Health Service 
        Act, including--
                    ``(A) any combination thereof; and
                    ``(B) when reasonably necessary to demonstrate 
                sameness, biosimilarity, or interchangeability for 
                purposes of this section, section 505, or section 351 
                of the Public Health Service Act (as applicable), any 
                product, including any device, that is marketed or 
                intended for use with such drug or biological product.
            ``(2) Eligible product developer.--The term `eligible 
        product developer' means a person that seeks to develop an 
        application for the approval of a drug under section 505(b) or 
        505(j) or the licensing of a biological product under section 
        351 of the Public Health Service Act.
            ``(3) License holder.--The term `license holder' means the 
        holder of an application approved under section 505(b) or 
        section 505(j) or a license under section 351 of the Public 
        Health Service Act for a covered product (including the 
        holder's agents, wholesalers, distributors, assigns, and 
        corporate affiliates).
            ``(4) REMS product.--The term `REMS product' means a 
        covered product that--
                    ``(A) is subject to a risk evaluation and 
                mitigation strategy under section 505-1; or
                    ``(B) is deemed under section 909(b) of the Food 
                and Drug Administration Amendments Act of 2007 to have 
                in effect an approved risk evaluation and mitigation 
                strategy under section 505-1.
    ``(b) Competitive Access to Covered Products as a Condition on 
Approval or Licensing.--As a condition of approval or licensure, or 
continuation or renewal of approval or licensure, of a covered product 
under section 505 of this Act or section 351 of the Public Health 
Service Act, respectively, the Secretary shall require that the covered 
product's license holder not adopt, impose, or enforce any condition 
relating to the sale, resale, or distribution of the covered product, 
including any condition adopted, imposed, or enforced as an aspect of a 
risk evaluation and mitigation strategy approved by the Secretary, that 
restricts or has the effect of restricting the supply of such covered 
product to an eligible product developer for development or testing 
purposes.
    ``(c) Competitive Access to Covered Products Other Than REMS 
Products for Development Purposes.--No license holder shall adopt, 
impose, or enforce any condition relating to the sale, resale, or 
distribution of a covered product that interferes with or restricts 
access to reasonable quantities of a covered product by an eligible 
product developer for development and testing purposes, at commercially 
reasonable, market-based prices, from the license holder or from any 
wholesaler or specialty distributor authorized by the license holder to 
commercially distribute or sell the covered product unless the license 
holder generally adopts, imposes, or enforces lawful conditions 
relating to the sale, resale, or distribution of a covered product, 
with respect to other buyers of the covered product.
    ``(d) Competitive Access to REMS Products for Development 
Purposes.--
            ``(1) Prohibited use of rems to restrict access.--With 
        respect to a REMS product, no aspect of a risk evaluation and 
        mitigation strategy under section 505-1 shall prohibit or 
        restrict, or be construed or applied to prohibit or restrict, 
        the supply of such REMS product to an eligible product 
        developer for development and testing purposes, at commercially 
        reasonable, market-based prices, from the REMS product's 
        license holder or from any wholesaler or specialty distributor 
        authorized by the license holder to commercially distribute or 
        sell the REMS product.
            ``(2) Single, shared system of elements to assure safe 
        use.--With respect to a REMS product, no license holder shall 
        take any step that impedes--
                    ``(A) the prompt development of a single, shared 
                system of elements to assure safe use under section 
                505-1; or
                    ``(B) the entry on commercially reasonable terms of 
                an eligible product developer into a previously 
                approved system of elements to assure safe use.
    ``(e) Procedures for Obtaining Access to Covered Products.--
            ``(1) Competitive access.--Notwithstanding any other 
        provision of law, in the case of an eligible product developer 
        that has an authorization to obtain a covered product in effect 
        under paragraph (2) or (3), no license holder shall adopt, 
        impose, or enforce any other condition relating to the sale, 
        resale, or distribution of such covered product that interferes 
        with or restricts access to reasonable quantities of the 
        covered product by the eligible product developer for 
        development and testing purposes, at commercially reasonable, 
        market-based prices, from the license holder or from any 
        wholesaler or specialty distributor authorized by the license 
        holder to commercially distribute or sell the covered product, 
        unless the license holder generally adopts, imposes, or 
        enforces lawful conditions relating to the sale, resale, or 
        distribution of a covered product, with respect to other buyers 
        of the covered product.
            ``(2) General covered products authorization.--Any eligible 
        product developer may seek a general covered products 
        authorization, authorizing the eligible product developer to 
        obtain any covered product for the purposes of development and 
        testing, by making a written request to the Secretary. Within 
        60 days after receiving such a request, the Secretary shall, by 
        written notice, issue such authorization if--
                    ``(A) the eligible product developer holds one or 
                more approved applications or licenses for a covered 
                product or, in the absence of such approvals or 
                licensures, otherwise establishes that the eligible 
                product developer can comply with the requirements of 
                this Act and other applicable law for the development 
                and testing of covered products; and
                    ``(B) the Secretary does not find that the eligible 
                product developer has materially failed to comply with 
                the requirements of this Act or other applicable law 
                for the development and testing of covered products.
            ``(3) Individual covered product authorization.--Any 
        eligible product developer may seek an authorization to obtain 
        an individual covered product for development and testing 
        purposes by making a written request to the Secretary. Within 
        60 days of receiving such a request, the Secretary shall, by 
        written notice, issue such authorization for purposes of--
                    ``(A) development and testing that does not involve 
                human clinical trials, if the eligible product 
                developer has agreed to comply with any conditions the 
                Secretary determines necessary; or
                    ``(B) testing that involves human clinical trials 
                if the eligible product developer has submitted a 
                protocol for testing that includes protections that 
                will provide an assurance of safety comparable to the 
                assurance of safety provided by any distribution 
                restrictions governing the approval or licensure of the 
                covered product or the license holder's distribution of 
                the covered product.
            ``(4) Failure by secretary to take final action.--If the 
        60-day period referred to in paragraph (2) or (3) expires 
        without the Secretary having taken final action on the request 
        for authorization, the Secretary shall be deemed to have 
        issued, by written notice, the requested authorization.
            ``(5)(A) Process for obtaining product pursuant to an 
        authorization.--If an eligible product developer is unable, for 
        purposes of development and testing, to obtain reasonable 
        quantities of a covered product commercially, either from the 
        license holder or from any wholesaler or specialty distributor 
        authorized by the license holder to commercially distribute or 
        sell the covered product, any eligible product developer that 
        has obtained authorization to do so, in accordance with 
        paragraph (2) or (3), shall be entitled to obtain such 
        reasonable quantities of such covered product at the same 
        commercially reasonable, market based price on which such 
        reasonable quantities of such covered product have been 
        previously sold by the license holder to third parties in the 
        open market. Such eligible product developer shall initiate its 
        acquisition of such covered product by providing a written 
        request for specific quantities of such covered product 
        either--
                    ``(i) to any wholesaler or specialty distributor 
                authorized by the license holder to commercially 
                distribute or sell the covered product; or
                    ``(ii) in the event no such wholesaler or specialty 
                distributor has been designated for such purpose by the 
                license holder, to the Secretary.
            ``(B) Request contents.--Such request shall include a 
        statement regarding the quantity of covered product sought for 
        development or testing purposes, and state that either--
                    ``(i) the eligible product developer has, or is 
                deemed to have, a general covered products 
                authorization under paragraph (2); or
                    ``(ii) the eligible product developer has, or is 
                deemed to have, an authorization under paragraph (3) to 
                obtain the specific covered product.
            ``(C) Disclosure of information by wholesalers and 
        specialty distributors.--In the event that a request is made to 
        a wholesaler or specialty distributor under this paragraph, the 
        wholesaler or specialty distributor shall not disclose to the 
        license holder of the covered product involved the identity of 
        the eligible product developer, but may disclose to such 
        license holder, only if required to do so by the holder--
                    ``(i) the fact that a request has been made;
                    ``(ii) the dates on which the request was made and 
                fulfilled;
                    ``(iii) the commercial terms on which the request 
                was fulfilled; and
                    ``(iv) the quantity of the covered product 
                furnished by the wholesaler or specialty distributor in 
                compliance with the request.
            ``(D) Disclosure pursuant to means specified by 
        secretary.--In the event that a request is made to the 
        Secretary under this subsection, then the Secretary shall, 
        within 5 business days of receipt of the request, notify the 
        license holder that a request for such covered product has been 
        made, and the quantity of the covered product requested, and 
        such license holder shall, within 30 days after receiving 
        notice from the Secretary, provide the quantity of the 
        requested covered product, through means specified by the 
        Secretary, at a non-discriminatory, commercially reasonable, 
        market-based price for which such covered product has been 
        previously sold by the license holder (or any wholesaler or 
        specialty distributor authorized by the license holder to 
        commercially distribute or sell the covered product) to third 
        parties in the open market. The means established by the 
        Secretary under this clause shall not disclose to the license 
        holder the identity of the eligible product developer that has 
        requested quantities of the covered product for development and 
        testing purposes.
            ``(E) Imminent hazard.--At any time, the Secretary may 
        prohibit, limit, or otherwise suspend a transfer of a covered 
        product to an eligible product developer if the Secretary 
        determines that the transfer of such product to the eligible 
        product developer would present an imminent hazard to the 
        public health. In such cases, the Secretary shall specify the 
        basis for the determination, including the specific information 
        available to the Secretary which served as the basis for such 
        determination, and confirm such determination in writing.
    ``(f) Public and Private Enforcement.--
            ``(1) Application of certain provisions.--For purposes of 
        this Act and the Public Health Service Act, a violation of a 
        requirement or prohibition in subsection (b), (c), (d)(1), 
        (d)(2), or (e)(1) shall be treated in the case of a REMS 
        product, as a violation of the product's risk evaluation and 
        mitigation strategy.
            ``(2) Remedies.--An eligible product developer that has 
        authorization for access to a covered product from the 
        Secretary under subsection (e) and that is aggrieved by a 
        violation of subsection (b), (c), (d)(1), (d)(2), or (e)(1) by 
        a license holder or any wholesaler or specialty distributor 
        authorized by the license holder to commercially distribute or 
        sell the covered product may sue such license holder for 
        injunctive relief and treble damages (including costs and 
        interest of the kind described in section 4(a) of the Clayton 
        Act (15 U.S.C. 15(a))).
    ``(g) Limitation of Liability.--The holder of an approved 
application or license for a covered product shall not be liable for 
any claim arising out of an eligible product developer's development or 
testing activities conducted under this section, including a claim 
arising out of a failure of the eligible drug developer to follow 
adequate safeguards to assure safe use of the covered product.
    ``(h) Reports.--
            ``(1) Report by fda.--Not later than 180 days after the 
        enactment of the Fair Access for Safe and Timely Generics Act 
        of 2014, and annually thereafter, the Secretary, acting through 
        the Commissioner of Food and Drugs, shall submit to Congress a 
        report that--
                    ``(A) identifies each instance of noncompliance by 
                any license holder with a requirement or prohibition in 
                subsection (b), (c), (d)(1), (d)(2), or (e)(1); and
                    ``(B) describes the actions taken by the Secretary 
                to remedy such noncompliance and to enforce such 
                requirements and prohibitions, whether by assessment of 
                a penalty or otherwise.
            ``(2) Report by ftc.--Not later than 270 days after the 
        enactment of the Fair Access for Safe and Timely Generics Act 
        of 2014, and annually thereafter, the Federal Trade Commission 
        shall submit to Congress a report that--
                    ``(A) describes the complaints received by the 
                Commission pertaining to the withholding of competitive 
                access to covered products, the actions taken by the 
                Commission with respect to each such complaint, and the 
                result of each such Commission action; and
                    ``(B) examines the impact on the market entry of 
                competing drug products, and the pricing and 
                availability of such products, in the United States 
                resulting from noncompliance by license holders with a 
                requirement or prohibition in subsection (b), (c), 
                (d)(1), (d)(2), or (e)(1).''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(ddd) Any violation by the license holder of a covered product 
(as such terms are defined in section 505-2(a) (including its 
contractors, assigns, or corporate affiliates)) of a requirement or 
prohibition in subsection (b), (c), (d)(1), (d)(2), or (e)(1) of 
section 505-2 (relative to competitive access to covered products for 
development purposes).''.
    (c) Waiver of Single, Shared System Requirement.--Section 505-
1(i)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
1(i)(1)(B)) is amended--
            (1) in clause (i), by striking ``or'' at the end;
            (2) in clause (ii), by striking the period at the end and 
        inserting ``; or''; and
            (3) by adding at the end the following:
                            ``(iii) the applicant for an abbreviated 
                        new drug application certifies that it 
                        attempted in good faith to create or negotiate 
                        entry into a single, shared system, but was 
                        unable to finalize commercially reasonable 
                        terms with the holder of the listed drug within 
                        120 days, and such certification includes a 
                        description of the efforts made by the 
                        applicant for the abbreviated new drug 
                        application to create or negotiate entry into a 
                        single, shared system.''.
    (d) Effective Date.--This section and the amendments made by this 
section shall take effect upon enactment, and shall apply to all 
approved applications or licenses for a covered product (as defined in 
section 505-2(a) of the Federal Food, Drug, and Cosmetic Act, as added 
by this section) regardless of whether those applications or licenses 
were approved before, on, or after the date of enactment of this Act.
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